Certified Copies

Hello,

Nowadays, we have techniques and oversight techniques to ensure that anything printed on paper is a certified copy of the original. However, how do we apply this when copies come from outside clinical trial sites? For example, a patient has an SAE and is admitted to a hospital that isn't the clinical trial site - the documents sent over from the admitting hospital are copies but not labelled as being certified, the originals (perhaps EMR) can never be compared with and a QC check of the copying process can't take place.

Is there a minimum standard that needs to be met in these circumstances?

Dear Billiejo, shouldn't we start with the question, whether the copies mentioned in your example need to be certified at all? The original documents still stay at the admitting hospital, you are not intending to replace any original by copies, the investigators receives a kind of "report" form the admitting hospital (a kind of dear doctor letter, discharge letter perhaps with attachments) - this is becoming part of the source at the investigational site. I personally would not expect a certification. But I am very interested in hearing others' feedback.
Kind regards,
Margit

I agree with you Margit. Unfortunately, the advice from regulators is not always so consistent or clear. For example, it appears to be acceptable for there not to be certification if the original is still in existence and is accessible for potential inspection if the scenario relates to the investigational site or another third party (i.e. sponsor holds copy and original exists at the site or a lab or some other location). However, if the sponsor holds a copy in their electronic trial master file (eTMF) and the original is still in existence and available for potential inspection but is held in the sponsor's archives, some regulators are insisting on the copy in the eTMF being certified. To my mind, this sounds like double-standards and lacking logic. If the original exists for verification (if needed) then it shouldn't matter if the original is held by the sponsor or a third party. In fact, there is an argument to say that certification would be more helpful in the cases where the site holds the original, to avoid having to make a separate inspection for verification purposes (the sponsor original being more accessible during a sponsor inspection).
Eldin.